CN107405448B - Method and apparatus for acquiring dose dialing events - Google Patents

Abstract

Systems and methods for detecting an energy pulse emitted by an injection device and determining a dose of a drug based on the pulse are disclosed. In one example, a module detects vibrations that are emitted as a result of dialing a click wheel on an auto-injector and determining a selected dosage of medication based on the dialed dosage.

Description

Method and apparatus for acquiring dose dialing events

Technical Field

The present invention relates to injection devices, and more particularly, to methods and devices for detecting a selected dose of medicament on an injection device. More particularly, the present invention relates to measuring the movement or vibration of an injection device to determine what dose of medicament has been selected by the user for injection.

Background

Injection devices are medical devices that allow patients to self-adjust their medication administration outside a hospital or doctor's office. These devices are often used to manage chronic diseases. Typical injection devices have a prefilled syringe in a mechanical device that employs a needle and delivers the drug with a single push of a release button. The amount of drug to be delivered can be selected using typical injection devices. The injection device can also be disposable and can include safety mechanisms to shield the needle before and after injection.

To effectively manage chronic diseases, self-administered patients maintain a log or history of many aspects of their daily lives. As part of the diary, the patient is expected to store or record the amount and time of each injection, as well as eating habits and motor laws. Missing or erroneous records in the log may result in incorrect injection information being stored. This may result in the patient incorrectly adjusting their future dose of medication and, together, in the medical staff making incorrect decisions with respect to the future medical regimen.

Without overcoming some of these drawbacks, existing injection devices include optical, capacitive, magnetic or similar methods for detecting how much medicament is injected into a patient. However, these prior art methods result in being large in size, making the device bulky and ergonomically unattractive. Some prior art injection devices are also designed to affect patient interaction with the injection device, for example by introducing a new dose dial button not originally designed for the injection device. Other existing injection devices detect the dose based on determining the position of a stopper inside a pre-filled cartridge before and after injecting the drug. However, these methods do not provide the ability to determine the direction or number of multiple individual dosing events that occur between two measurements.

Disclosure of Invention

One aspect of the present invention is a method for detecting an energy pulse emitted by an injection device, determining a dose of medication based on the pulse, and communicating this information to a patient. In this embodiment, the module is configured to detect the emitted energy pulse by selecting a dose of the drug, and to determine the selected dose from the direction and amplitude of said pulse.

One embodiment is a method for detecting at least one dialing event of an injection device. The method may comprise: detecting a pulse delivered by the injection device, wherein the pulse relates to at least one external event; determining event parameters from the pulses; and determining that the external event is a dialing event based on the event parameter.

The foregoing and/or other aspects of the present invention are achieved by providing a module containing one or more sensors for vibration and directional motion transmitted to the injection device, and the module is attachable to the body of the injection device.

In one embodiment of the invention, data regarding at least one dialing event of the injection device can be communicated to an external device.

Another embodiment of the invention is a module for detecting dose dialing parameters. The module comprises: a carrier configured to mate with an injection device; one or more sensors mounted on the carrier; and a processor configured to read a parameter and detect a dialing event based on the parameter.

Drawings

Aspects of the present disclosure will hereinafter be described in conjunction with the appended drawings, provided to illustrate, but not to limit, aspects of the disclosure, wherein like designations denote like elements.

Fig. 1A-C depict an injection device having a module according to an exemplary embodiment of the present invention. Fig. 1A is a perspective view of one embodiment of a syringe with an attached external module. Fig. 1B is a side perspective view of an injection with adjacent outside modules. Fig. 1C is a lower perspective view of an injector with adjacent outer modules.

FIG. 2 depicts a schematic diagram of a module according to an exemplary embodiment of the invention;

fig. 3 depicts a flow chart of an embodiment of a system for monitoring a selected dose on an injection device according to an illustrative embodiment of the invention.

Fig. 4 depicts a flow chart of an embodiment of monitoring a dose dialing event on an injection device according to an exemplary embodiment of the present invention.

Fig. 5 depicts a flow chart for determining implementation in an injection device according to an exemplary embodiment of the present invention.

Fig. 6 depicts a flow chart of an embodiment of determining that the event is a dose dialing event according to an illustrative embodiment of the invention.

Fig. 7A-D depict graphs illustrating dose dialing event signatures according to exemplary embodiments of the present invention.

Fig. 8 depicts an alternative embodiment of an injection device having a module secured to a cap in accordance with an exemplary embodiment of the present invention.

Detailed Description

As will be appreciated by those of ordinary skill in the art, there are many ways to carry out the examples, modifications and arrangements of the drug delivery device or injection device according to embodiments of the present invention. While the illustrative embodiments will be described in the drawings and in the following description, the embodiments disclosed herein are not intended to be exhaustive of the various alternative designs and embodiments disclosed. Those skilled in the art will readily appreciate that various modifications and combinations may be made without departing from the invention.

Embodiments of devices and methods for detecting dose dialing event parameters on an injection device are discussed herein and are described in more detail below in conjunction with fig. 1-8. One embodiment includes a module designed to be attached to an external body of an injection device, such as an auto-injector, a disposable injection device, or a continuous injection device with interchangeable pre-filled cartridges. For example, the device may be adapted for attachment to a PHYSIOJECT^TMAuto-injector, VYSTTM disposable pen, or Becton

The reusable pen of (1). In this embodiment, the module is configured to be attached to the exterior of the injection device. This allows the module to be designed to be compact and lightweightLow power and low cost module for detecting the dialed number amount. When a user rotates a dial on the injection device, the module detects a parameter related to the rotation and determines a dose selected by the user. As will be discussed in more detail below, the module may detect motion or vibration that is felt by the dialing process and distinguish this data from the precise dose selected by the user on the injection device.

Another embodiment comprises a module integrated into a safety cap of an injection device. In this embodiment, the module can be initially designed as the cap and placed on the injection device to replace the original cap.

In an exemplary embodiment, the module can include one or more sensors that can monitor and detect external events related to the use of the injection device. This can include sensors for orientation, motion, directional motion, sound and vibration experienced by the injection device due to an external event. The module may detect the direction of movement and vibration of an external event before, during, and after use of the injection device. The module also includes a microprocessor configured to process data from the sensor to determine whether an external event is a dose dialing event or an extraneous event mistaken for a dose dialing event, such as an additional tap on the injection device. Once a dose dialing event is detected, the microprocessor may determine the total selected dose based on the direction and/or number of multiple dose dialing events that occur when the user selects the appropriate number of medications to be administered.

The processor may be programmed or configured to determine a set of event parameters based on data from the sensors. Injection devices, such as insulin pens for the management of diabetes, are designed to generate feedback on the sudden release of mechanical energy each time a dose is selected. The sudden release of mechanical energy is indicated to the user by an audible click and tactile feedback. Within the injection device, the release of mechanical energy results in all the motion and vibrations transmitted through the injection device body or internal air space. A sensor in the module is configured to detect the release of mechanical energy, and the microprocessor may be configured to analyze data from the sensor to determine a number of dialing events. Similarly, the sensor may detect the direction of the net inertial force with respect to the pulse energy, and the sensor may be programmed to analyze data from the sensor to distinguish between a dose increase event (e.g., "dial up") and a dose decrease event ("dial down").

The processor may also be programmed or configured to determine whether the event parameter exceeds a predetermined threshold. For example, the magnitude and direction of the force due to an accidental tap may be represented by a specified threshold. In one embodiment, the threshold may isolate the dose dialing event from any external disturbances or events by performing a representative number of controlled studies. The controlled study can include measuring and/or monitoring controlled dose events ("clicks"). In one embodiment, the threshold can be determined as a minimum value of any of the controlled dose dialing events. In another embodiment, the threshold may be determined as an average of the controlled dose dialing events. In one embodiment, the threshold is specified as a formula that indicates that an event parameter must exceed the processor to recognize an external event as a dose dialing event. For example, the processor may be programmed or configured to analyze data from the sensor due to an external event, determine an event parameter for the external event, and compare the event parameter to the threshold. If the comparison indicates that the event parameter does not exceed the threshold and is therefore not associated with a dose dialing event, the processor rejects the event, such as when an accidental tap is detected by the sensor. Thus, if the processor determines that the event parameter exceeds the threshold, the processor may be configured to classify the external time as a dose dialing event.

The processor may be further programmed or configured to count or track the number and direction of the dose dialing events to determine a total selected dose for a given injection of medicament ("injected dose"). The processor may determine whether the external event is a dialed dose event and a direction of the dose dialing event (e.g., dial up or dial down). For example, when selecting a two unit dose of medicament, the user may operate the dose dial mechanism by dialing up three doses, thereby incrementing the selected dose by three units. The user may then recognise the error and operate the mechanism by dialing down one unit to obtain the desired dose of two units. The processor may be programmed or configured to determine the occurrence of each dose dialing event according to the event parameters explained herein. Further, the processor may be programmed or configured to distinguish between an up-dialling dose dialling event and a down-dialling dose dialling event in dependence on the event parameter. The processor may accept the event parameters and apply an algorithm to determine a total selected dose.

In an exemplary embodiment according to the invention, the module may further comprise a communication module to allow connectivity between the injection device and an external device. The communication module is capable of communicating information from the module to interested parties, including patients, payers, pharmacies, and clinicians. For example, before use, the module is connected to an application running on a portable electronic device, such as a smart phone or a digitizer. This connection may use a well-known wireless communication protocol, e.g.

WIFI or other means. Once the application detects a connection to the module, data from on-board sensors may be passed to the application for display to a user. For example, both the total selected dose for an injection event and the total selected dose selected event may be displayed. In another embodiment, a chart or graph showing the measured event parameters may be displayed to the user. In another embodiment, a history or log of the number of injection events and total selected doses may display a given period of time, such as the previous day, week, month, etc.

As mentioned above, the module may be configured and shaped to retrofit pre-existing injection devices. The module may be placed along the body of the injector so that the position of the module does not prevent activation or movement of any existing function of the injection device. Further, the module may include an electronic switch or lever that is activated upon the occurrence of an activation event. In this regard, an activation event may attach the module to the body of the injection device or an external event may occur. Thus, in one embodiment, the module is capable of detecting that a user activates the injection device to administer a medicament. This allows additional functionality to be designed into the module. For example, upon detecting an activation event, the smart module can pass a signal to any connected external device. The external device may be a computer or a portable electronic device that records the time and date of the activation in order to assist the user in tracking the time at which the injection occurred.

In one embodiment, the module is placed in an insulin injection device configured to deliver insulin to a diabetic patient. Upon delivery, the module may detect the injection event and transmit a signal to the electronics running a software program that tracks the dose dialing event parameters and injection event information for the injection to the patient. Because diabetics administer insulin several times a day, the present disclosure provides a simple and efficient mechanism that allows patients to track the date and time of their insulin injections. In some embodiments, the module may detect the amount of insulin given by the injection device.

In an exemplary embodiment, the injection device may be disposable. In some embodiments of the invention, the module may also be disposable. In other embodiments, the module may be removed and placed on a different disposable injection device to continue monitoring the drug being administered while the different injection device is switched on and off. In yet another embodiment, the module may be designed as a safety cap or other element that protects the needle from administering medication. In this embodiment, the module may be included in the safety cap according to the original design, replacing the original safety cap, and a smart cap can be retrofitted, further avoiding interference with any existing functionality of the injection device.

In the following description specific details are given to provide a thorough understanding of the examples. However, it will be understood by those of ordinary skill in the art that the examples may be practiced without these specific details. For example, electrical components/devices may be shown in block diagrams in order not to obscure the examples in unnecessary detail. In other examples, these components, other structures, and techniques are shown in detail to further explain the examples.

It is also noted that the examples may be described as a process, which is depicted as a flowchart, a flow diagram, a finite state diagram, a structure diagram, or a block diagram. Although a flowchart may describe the operations as a sequential process, many of the operations can be performed in parallel or concurrently, and the process can be repeated. Additionally, the order of the operations may be re-ordered. A process may correspond to a method, a function, a procedure, a subroutine, a part procedure, etc. When the program corresponds to a software function, its terminal replies to the function corresponding to the calling function or the main function.

Those of skill in the art would understand that information and signals may be represented using any of a variety of different technologies and techniques. For example, data, instructions, information, signals, bits, symbols, and chips that may be referenced throughout the above description may be represented by voltages, currents, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof.

While various fluids may be employed in exemplary embodiments of the present invention, the fluid in the injection device will be referred to hereinafter as the "drug".

Various inputs can be implemented using the exemplary embodiments of this invention, including but not limited to mechanical buttons, touch inputs, voice control inputs, or any other input known in the art. For simplicity, hereinafter, the input will be alternatively referred to as a "button" or a "trigger".

Fig. 1A-1C depict an exemplary embodiment of an injection device 100. The injection device 100 includes an elongated cylindrical body 108 having an injection button 106 positioned on one end of the injection device 100. An injection button 106 activates the injection device to discharge insulin (not shown) into the user. Thus, when the injection button 106 is engaged, insulin inside the injection device 100 is used, whereby the medicament is injected into the user. Safety cap 102 is located at the distal end of body 108 and is configured to prevent a user from inadvertently contacting insulin.

The injection device 100 is also equipped with a dose dial mechanism 104. In the embodiment shown in fig. 1A, the dose dialing mechanism 104 is depicted proximate to the injection button 106. However, it should be appreciated that the location of the dose dialing mechanism 104 may be located anywhere along the injection device body 108. The dose dialing mechanism 104 is configured to allow a user to easily and quickly dial an injection quantity or dose. For example, the user may operate the dose dialing mechanism 104 to dial, increase or decrease the amount of medicament.

The injection device 100 also includes a viewing window 105 (fig. 1C) that allows the user to view the amount of medicament selected by the dose dialing mechanism 104. In one embodiment, the viewing window 105 may display the amount of the drug. In another embodiment, the viewing window 105 may display increments of medication equal to a single dose, such that each dose is one unit of the amount of medication equal to the user's particular medical regimen.

Operation of the dose dialing mechanism 104 is configured to generate tactile and audible feedback as each dose increment (typically one unit) occurs. In one embodiment, the tactile feedback is perceptible to the user as a result of the two elements being abruptly discharged temporarily interfering with each other, causing the user to perceive the mechanical energy feedback. In another embodiment, incremental adjustment of the medication dose results in an audible and tactile "click" in response to each dialed dose increment. The tactile and audible feedback can be heard and felt by the user when operating the dose dial mechanism to increase or decrease the dose.

In yet another embodiment, the dose dialing mechanism 104 can be designed to include at least two components that move relative to each other, a top rim and a cam (not shown). In this embodiment, the two components interfere with each other each time a dose increment is dialed by the user. The disturbance is periodically interrupted at each dose increment, resulting in a temporary and sudden discharge of mechanical energy. This discharge or impact of mechanical energy is then transmitted through the pen body and the surrounding air to produce acoustic and tactile feedback.

Fig. 1 also depicts a dose detection module 110, the dose detection module 110 being attached to the outside of the injection device body 108. The dose detection module 110 is configured to be rigidly connected to the body 108 and includes at least one sensor to detect the release of mechanical energy, including the direction and magnitude of the impact. Once detected, these parameters are filtered and interpreted by an algorithm, thereby determining the dose selection direction, e.g., dial-up or dial-down, and the incremental change in dose.

The module 110 comprises at least one connection bracket 114 for rigidly attaching the dose detection module 110 to the injection device body 108. In one embodiment, the module 110 may be cylindrical and configured to be reversibly mounted to an outer housing or cap of the injection device 100. In one embodiment, the module 110 may include tabs, clips, brackets, or other structures for mounting the injection device 100.

In the embodiment shown in fig. 1, the attachment bracket 114 includes two tangs, shown as providing a secure mounting, mating (and dismounting) the module 110 to the injection device body 108 by clamping (or other methods known in the art). The module 110 can be manufactured to be installed along the injection device body 108 in a manner and location that does not affect the existing functionality of the injection device 100. In one embodiment, the module may be secured to the body 108 remote from the dose dial member 104 and the viewing window 105.

In an exemplary embodiment according to the present invention, the dose detection module 110 allows a user to view one or more status indicators 112 disposed on the module 110. One or more status indicators 112 may be part of the module 110 and indicate the condition or status of the device. The status indicator 112 may include one or more lights, such as light emitting diodes ("LEDs") or any other visible, audible, or tactile stimulus. The use case or condition may include, but is not limited to, an out-of-range case (e.g., loss of connectivity) or a temperature alarm.

In another exemplary embodiment according to the present invention, the module 110 may include a micro switch 116. The microswitch 116 is operable to activate the module 110. In one embodiment, the microswitch 116 may be activated when the module 110 is attached to the injection device 100. In this regard, the module 110 is activated upon attachment to the injection device 100 and continuously monitors for external events until power is turned off or removed from the injection device 100. In another embodiment, the user 116 may actively operate the microswitch by pressing a button to turn the module 110 on or off as desired.

It should be appreciated that the injection device 100 can function without the module 110 to inject medication into a user. The module 110 is designed to add electronic monitoring and reporting capabilities to existing injection devices. Thus, the module 110 can be attached to the injection device 100 after manufacture, but without changing the existing functionality of the injection device 100. In an exemplary embodiment according to the invention, the injection device 100 can be a PHYSIOJECT from Becton Dickinson^TMAuto injector, VYSTRA^TMDisposable Pen (Pen) or reusable Pen. It should be recognized that other injection devices are also contemplated as being within the scope of the present invention.

Fig. 2 depicts a schematic diagram of elements within the dose detection module 110 according to one embodiment. The module 110 is configured to monitor and detect external events and characterizations related to the dialing of a dose of an injection device. The module 110 can also notify the user of various external events and characterizations of the injection device through visual, aural or tactile stimuli, or can communicate to an external device 270.

In an exemplary embodiment according to the invention, the module 110 includes a processor 205 in electrical communication with a sensor module 210. The sensor module 210 includes a motion sensor 212 and a vibration sensor 214. The processor 205 is also connected to the indicator 112, the clock 230, the power supply 240, the microswitch 106, the storage 280 and the working memory 250. In addition, the processor 205 is connected to a memory 220, the memory 220 having modules that store data values that define instructions that configure the processor 205 to perform the functions of the module 110. Memory 220 includes a filtering module 221, an event determination module 222, an event value determination module 224, a threshold determination module 225, and a dialing event determination module 226. In one embodiment, the processor 205 is also connected to a communication module 260 that communicates with an external device 270, either wired or wirelessly. External device 270 includes a communication module 278, applications 272, and a display 274. It should be appreciated that these components can be mounted within the module 110 while allowing the module 110 to be attached to an injection device.

In an exemplary embodiment according to the invention, data from the sensor module 210, such as sensor data, may be recorded, communicated, or indicated through a series of steps. In an exemplary embodiment according to the present invention, the sensor module 210 is activated when the microswitch 106 is activated. In response, the sensor module 210 detects the occurrence of an external event and generates sensor data that is communicated from the sensor module 210 to the processor 205. In one embodiment, the processor 205, using instructions from the memory 220, performs on-board processing to determine whether the external event is a dose dialing event. In one embodiment, the processor 205 determines whether one or more event parameters exceed a predetermined threshold. In an alternative embodiment, sensor data from the sensor module 210 can be recorded in the memory 250 and transferred to the external device 270. In another embodiment, the processor 205 is configured to determine the number of dose dialing events and the direction of each dialing event to determine the selected dose for an injection event.

In an exemplary embodiment according to the invention, the sensor module 210 includes sensors configured to detect external events, such as events external to the module 110. For example, the sensor module 210 may include a motion sensor 212 and a vibration sensor 214 configured to, but not limited to, motion, orientation, vibration, and sound from the dose dialing mechanism 104 of the injection device 100 being operated by the user. In another embodiment, the sensor module 210 may be used to detect temperature, proximity, amount of drug within the injection device, or amount of drug injected by the injection device. In one embodiment, the motion sensor 212 and the vibration sensor 214 comprise a single axis accelerometer configured relative to the injection device body such that the accelerometer is capable of sensing motion imparted on the injection device body from an external event. In this regard, the single axis accelerometer may be oriented perpendicular to the longitudinal axis of the injection device. In another embodiment, motion sensor 212 and vibration sensor 214 include multiple accelerometers, such as single axis and/or 3D accelerometers, thereby enabling detection of directional motion and vibration in multiple directions and increasing directional sensitivity.

In another embodiment, the sensor module 210 can include additional sensors that detect the status of the device data. In one embodiment, the sensor module 210 may include a microphone to detect acoustic vibrations occurring around the module 110. For example, the microphone may be used to detect sounds characteristic of other functions of the injection device, such as, but not limited to, injection of a medication, tapping associated with a dose dialing mechanism, or other sounds characteristic of operating the injection device. In another embodiment, the sensor module 210 may include a temperature sensor that detects the temperature experienced by the injection device during use, storage, or after use. In this regard, sensor data from the temperature sensor may be communicated to the indicator 112 to inform the user of device status information based on the temperature data. In yet another embodiment, the sensor module 210 can include a proximity sensor. In embodiments using proximity sensors, the sensor module 210 may detect an out-of-range condition of the module 110. For example, out-of-range conditions may include, but are not limited to, proximity of module 110 to the injection device, proximity of module 220 to external device 270, or loss of data connectivity in communication module 260. The sensor module 210 may then communicate the out of range data to the indicator 112, and the indicator 112 may notify the user of the presence by any form of stimulus, such as visible light, sound, or tactile notification.

In another embodiment, the sensor module 210 may include additional sensors configured to provide additional sensing to assist in evaluating external events. For example, the microphone can be used to detect sounds characteristic of the functioning of the injection device, such as removal of a safety cap or use injection of a drug. Such sounds may indicate that the detected external event relates to an unrelated event (e.g., an injection event) as opposed to a dose dialing event. In another embodiment, an additional accelerometer can be used to detect removal of the safety cap prior to administering a dose. In yet another embodiment, the additional accelerometer can also be used to detect injection device orientations, such as motion and orientation, that are typically associated with an injection event. It should be appreciated that although illustrative examples are provided herein, the sensor module 210 can be configured with any sensor known in the art and configured to indicate and support whether the external event is a dose dialing event, an unrelated event, or a result of a general injection device use.

In an exemplary embodiment according to the invention, the processor 205 is also connected to the indicator 112. In response to the sensor module 210, the indicator 112 can indicate the status of the device to a user. For example, when indicator 112 includes one or more LEDs, the one or more LEDs may be activated and emit light in response to sensor data. In another embodiment, the indicator 112 can inform the user of the condition or status of the device. Examples of conditions or states of the state include, but are not limited to, ready for use, no ready, default, refrigerated, and the like. The one or more LEDs may indicate different conditions to the user by the color, duration or repetition of the light radiation.

In an exemplary embodiment according to the invention, the processor 205 is connected to a clock 230 or similar mechanism included in the module 110. The clock 230 may continuously update internal events in the memory 220 and the working memory 250 of the module 110. The processor 205 can continuously check the internal clock 230 and compare with data obtained from the sensor module 210 or the memory 220 while processing algorithms described further herein.

In an exemplary embodiment according to the invention, the processor 205 is connected to a power supply 240. The power supply 240 provides power to the rest of the module 110. In one embodiment, the power supply 240 may be a battery included in the module 110. In this embodiment, the module 110 may be configured to have sufficient power and battery life so that it can monitor weeks, months, or years during operation of the injection device 100. In another embodiment, the power supply 240 may be a power supply disposed external to the module 110 (e.g., on the injection device 100 or other external location).

In an exemplary embodiment according to the present invention, processor 205 is connected to microswitch 106. The microswitch 106 can be activated when the module 110 is attached to the injection device or when an injection event occurs. Upon activation of the module 110, the power supply 240 supplies power to the module 110, activating the various components of the module 110, including the processor 205.

In an exemplary embodiment according to the invention, the processor 205 can be configured to store or transfer data to the working memory 250 and/or the storage 280. Working memory 250 may be used by processor 205 to store data that is dynamically generated during operation of module 110. For example, instructions from modules stored in memory 220 may be stored in working memory 250 when processor 205 executes. The working memory 250 may also store dynamic runtime data, such as stack or heap data used by programs executing on the processor 205. The storage 280 may be used to store data generated by the module 110. For example, event parameters or dose dialing events may be stored in the reservoir 280. In another embodiment, sensor data from the sensor module 210 can be stored in the working memory 250 and/or the storage 280 or communicated to the external device 270 via the communication module 260.

In an exemplary embodiment according to the present invention, the memory 220 may be considered a computer-readable medium and stores several modules. The modules store data values that define instructions for the processor 205. These instructions configure the processor 205 to perform the functions of the module 110. For example, in certain aspects, memory 220 may be configured to store instructions that cause processor 205 to perform process 300 or portions thereof as described below. In the illustrated embodiment, the memory 220 includes a filtering module 221, the filtering module 221 providing instructions to configure the processor 205 to interpret and analyze data received from the sensor module 210. The memory 220 can further include an event parameter determination module 222, the event parameter determination module 222 providing instructions to configure the processor 205 to determine an external time parameter of an external event based on the sensor data interpreted and analyzed by the filtering module 221. The memory 220 further comprises an event value determination module 224, the event value determination module 224 providing instructions to configure the processor 205 to determine a representative event value based on the external event parameter. The memory 220 can further include a threshold determination module 225, the threshold determination module 225 providing instructions to configure the processor 205 to determine and/or specify a threshold. Additionally, the memory 220 can include a dialing event determination module 226 that provides instructions to configure the processor 205 to determine whether the external event is a dose dialing event based at least in part on the external event parameters and the threshold. It should be appreciated that memory 220 is not limited to the modules noted above, and that memory 220 may include additional modules, fewer modules, or a combination of modules providing substantially the same instructions to configure processor 205 to perform substantially similar functions. The functionality discussed above will be described in more detail below with reference to the above-described modules depicted in fig. 2.

The filtering module 221 includes instructions that configure the processor 205 to interpret and apply filters to data received from the sensor module 210. The instructions in the filtering module 221 may configure the processor 205 to apply a low power filter to interpret sensor waveforms representative of external event characteristics. The instructions in the filtering module 221 may also configure the processor to separate or partition the external event features into separate components, such as a direction component and a magnitude component. Thus, the instructions in the filtering module may be a mechanism for interpreting, filtering, and analyzing the raw signals from the sensor module 210.

The instructions in the event parameter determination module 222 configure the processor 205 to determine external event parameters for the external event detected by the sensor module 210. The instructions in the event parameter determination module 222 configure the processor 205 to determine a time parameter based at least in part on the components determined by the filtering module 221. The event parameters may include the direction and magnitude of an external event as detected by the sensor module 210. Thus, the instructions in the event parameter determination module 222 may represent one means of determining the event parameters based at least in part on the shock experienced by the injection device 100 as a result of the external event. The event parameter determination module 222 may also include configuring the processor 205 to record the event parameters in the storage 280 or the working memory 250.

Instructions in the event value determination module 224 configure the processor 205 to determine a representative event value or a calculated waveform based at least in part on the event parameter. For example, the direction component waveform may be combined with the magnitude component waveform to form a calculated waveform that is attributed to an external event. In particular, the event value determination module 224 may include configuring the processor 205 to multiply the low frequency component by the high frequency component to result in a calculated waveform.

The instructions in the threshold determination module 224 configure the processor 205 to specify a critical value based at least in part on a predetermined threshold. In one embodiment, the threshold can be determined experimentally by performing a representative number of controlled studies to isolate dose dialing events to form any extraneous perturbations or events. The controlled study can include measuring and/or monitoring controlled dose dialing events ("clicks"). In one embodiment, the threshold can be determined as a minimum of any controlled dose dialing events. In another embodiment, the threshold value may be determined as an average of controlled dose dialing events. In one embodiment, the threshold value may be predetermined and stored in the storage 280 and/or the working memory 250. The threshold determination module 224 may include configuring the processor 205 to retrieve the threshold value from the storage 280 and/or the working memory 250. In another embodiment, the threshold determination module 225 may include instructions that configure the processor 205 to determine the threshold value based at least in part on a controlled study of the sensor module 210 detected indicating a desired dose dialing event. In yet another embodiment, the threshold determination module 224 may include instructions that configure the processor 205 to dynamically adjust the threshold to a dynamically updated dose dialing event based on a predetermined dose dialing event, for example, by using event parameters determined by the processor 205. Thus, the threshold determination module 224 represents one configuration for specifying a threshold value based at least in part on the expected daily handling of the injection device 100.

Instructions in the dialing event determination module 226 configure the processor 205 to determine whether the external event is a dialing dose based at least in part on the external event and a threshold value. The threshold value can be specified as a formula that represents the characteristics to the processor 205 that the actual dose dialing event parameters must exceed to identify the external time as a dose dialing event. In one embodiment, the instructions in the dialing event determination module 226 may configure the processor 205 to compare the external event value to the threshold value. If the external event value exceeds the threshold, the dialing event determination module 226 may provide instructions to configure the processor 205 to record the external event as a dialing event in the working memory 250 or the storage 280. Alternatively, if the comparison indicates that the external event value does not exceed the threshold and is therefore not associated with a dose dialing event, the processor 205 rejects the external event, for example when an accidental tap is detected by the sensor module 210. In another embodiment, the dialing event determination module 226 may further include instructions that configure the processor 226 to count or track the number and direction of each external event. In one embodiment, the number of external events may relate to a selected dosage amount value. In another embodiment, the number of external events may be a factor in determining whether the external event is a dose dialing event or an unrelated external event. For example, a single isolated external event may represent an accidental tap, as a single event may involve a dose dialing event. In this case, the user may increase or decrease the dose size by more than one dose dialing operation. Thus, dialing event determination module 226 represents a mechanism for determining that a dose dialing event has occurred and tracking the number of dose dialing events.

In the illustrative embodiment according to the present inventionIn an embodiment, the processor 205 can be further configured to communicate the data to the communication module 260. The communication module 260 is capable of wired or wireless communication, cellular communication,

A local area network, wireless local area network, RF, IR, or other communication methods or systems known in the art are connected to the network. In one embodiment, the communication module 260 is a BLF module that communicates data over a Bluetooth connection. In another embodiment, the communication module 260 communicates the data to the home health monitor using a cloud connection.

In an exemplary embodiment according to the present invention, upon receiving dose dialing event or injection event data, the communication module 260 is capable of communicating the data to the external device 270. The external device 270 can be a mobile device, a home health monitor, a computer, a server, or any other external device. This allows device data to be communicated to a user, payer, pharmacist, doctor, nurse, family member, or other desired party.

In an exemplary embodiment according to the present invention, external device 270 includes an application 272, a display 274, and a communication module 278. The external device 270 is configured to receive data from the communication module 260 of the module 110 via the communication module 278 of the external device running the application 272. In one embodiment, the communication module 260 communicates with the external device 270 through a bluetooth connection. In one embodiment, display 274 allows a user to read data on external device 270. In another embodiment, external device 270 can be a mobile handset or a digitizer running application 272. In one embodiment, the device data is communicated to the user's external device 270, and via application 272, the user determines whether they are forwarding information to a payer, pharmacist, doctor, nurse, or other third party. In another embodiment, the application 272 allows the user to select to whom he wants to communicate data. In an alternative embodiment, the device data is communicated directly to a payer, pharmacist, doctor, nurse or other third party.

In an alternative embodiment according to the present invention, data can be transferred from module 110 to external device 270 through a series of steps. The communication module 260 receives data from the processor 205 or any component included in the module 110. The communication module 260 then initiates a communication connection with the communication module 278 of the external device 270. The communication module 260 then communicates the data to the external device 270. External device 270 includes a device configured to accept data from module 110, store the data in a computer-readable memory of external device 270 or in the cloud, and display the data to a user via display 274. In another embodiment, external device 270 receives data from communication module 260 and, after receiving the data, passes the data to another location, such as a server computer.

Fig. 3 depicts a flowchart of an exemplary embodiment process 300 for a method of monitoring a dose magnitude selected on an injection device, such as the injection device 100 depicted in fig. 1-2. The process 300 begins at a start step and then moves to step 310 where a module, such as the dose detection module 110, is initialized. In one embodiment, this initialization occurs when the module is placed on the exterior of the injection device, for example by operating microswitch 106. In another embodiment, the module can be mechanically initialized by a user or other mechanical input. In an alternative embodiment, the module can be activated in response to wireless communications received by a communication module of the module. In yet another embodiment, the module can be initialized at the start of an external event.

After initialization, the process moves to process step 320, where the module 110 is configured to detect a dose dialing event. The module 110 is configured to detect an external event and determine whether the external event is a dose dialing event. The function of step 320 will be explained in further detail below with reference to fig. 4. After the module 110 determines that a dose dialing event has occurred at step 320, the process 300 moves to decision step 330 where it is determined whether the external event is a dose dialing event at decision step 330. If the external device is not determined to be a dose dialing event, the process returns to step 320 to continue monitoring for external events.

If it is determined in step 330 that the external event is a dose dialing event, process 300 moves to decision step 340 where a determination is made in decision step 340 whether the dose dialing event is a new dose dialing event. If the dose dialing event is not a new dose dialing event, the system is idle and remains at decision step 340 to continue monitoring for new dose dialing events.

At decision step 340, process 300 determines whether the dose dialing event is a new dose dialing event. In one embodiment, it is determined that a new dose dialing event has occurred based on the event parameter and a specified threshold, which are explained in further detail below with reference to fig. 4-6. Decision step 340 determines that the event parameter at a given time has decreased below the specified threshold. In one embodiment, the determination of decision step 340 is made by the dialing event determination module 226, whereby the dialing event determination module 226 continues to compare the event parameters to the specified threshold. If the event parameter does not decrease below a specified threshold, the process remains idle to continue monitoring the event parameter and threshold. If it is determined at decision step 340 that the event parameter has decreased below a specified threshold, then the process 300 determines that the dose dialing event is a new event.

If a determination is made at decision step 340 that the dose dialing event is a new dose dialing time, the process moves to step 350. At step 350, the dose dialing event is stored in a memory of the module, such as working memory 250 or reservoir 280. By storing the new dose dialing event, process 300 is able to determine, track, and count the total dose magnitude as a function of the event parameters. In this way, the module 110 is able to record the number of times the user operates the dose dialing mechanism and the direction of such operation ("dial-up" or "dial-down").

After process 300 updates the dose dialing event at step 350, process 300 moves to step 360 where the dose dialing data is communicated to an external device. The communication can be managed by a communication module, such as communication module 260 depicted in fig. 2. The external device can be a mobile phone, a computer, or a server, such as external device 270 depicted in fig. 2. Although not shown in the embodiment of fig. 3, it is recognized that the user, payer, pharmacist, doctor, nurse or other third party may access the data through an external device to monitor and manage drug dynamics based on the transferred dose dialing data.

Fig. 4 depicts a flowchart of a process 330 for detecting a dose dialing event in an injection device according to an exemplary embodiment of the present invention. The process 330 begins at a start step and then moves to step 410 where an external event is detected in step 410. External events are detected by sensors included in the module 110. For example, the external event can be detected by the sensor module 210 as depicted in fig. 2. In one embodiment, the motion sensor and the vibration sensor are configured to detect an impact of mechanical energy propagating through the injection device as a result of an external event. The sensor module includes one or more sensors including, but not limited to, accelerometers, microphones, temperature sensors, proximity sensors, optical sensors, and the like. In one embodiment, sensor data can be collected from a single axis accelerometer at a sampling frequency of 30 kHz. In another embodiment, the processor 205 can be configured to receive sensor data from the sensor module 210 based on detected external events and record the sensor data in the working memory 250 or storage 280 for later access and on-board processing.

After the sensor detects an external event in step 410, the process 330 moves to step 420 where the event parameters are determined in step 420. The function of process step 420 will be explained in further detail below with reference to fig. 5. After module 110 analyzes the external event in process step 420, the process moves to process step 430, where module 110 determines whether the external event is a dose dialing event or an unrelated event. The function of the process step 430 will be explained in further detail below with reference to fig. 6.

FIG. 5 depicts a flowchart of a process 420 of an exemplary embodiment for determining event parameters for an external event. In one embodiment, the external events are analyzed by the instruction processor 205, which is configured to base the analysis on the instructions from the filtering module 221 and the event parameter module 222. The process 420 begins at a start step and then moves to step 510 where the sensor data is acquired from sensors of a module, such as the sensor module 210 depicted in FIG. 2, in step 510. In one embodiment, the processor 205 is capable of retrieving sensor data from the working memory 250.

After the sensor data is acquired, process 420 moves to step 520 where the sensor data is filtered in step 520. In one embodiment, the sensor data includes a description of an external event, which is passed to a small, low power filter unit, such as the filter module 221 depicted in FIG. 2.

In an exemplary embodiment according to the invention, the sensor data is filtered and split into two components. One component is called the "direction component" and represents data about the direction of the external event. In one embodiment, the directional component is sensor data of a low frequency waveform. The low frequency sensor data may include information about all motion of the accelerometer. In an exemplary embodiment according to the present invention, all movement of one or more accelerometers may represent a "click direction" or direction of movement on the dose dialing mechanism. In another embodiment, the low frequency component may be sensor data having a frequency of less than 100 Hz.

The second component, the "magnitude component", can represent data about the magnitude of the external event. In one embodiment, the amplitude component is sensor data of a high frequency waveform. The high frequency sensor data may include information about vibrations in the audible frequency range. In an exemplary embodiment according to the present invention, the vibrations in the audible frequency range may represent a "click sound" or a sound generated by movement on the dose dialing mechanism. The vibrations may be vibrations in the air surrounding the module 110 or vibrations propagating through the body of the injection device. In another embodiment, the high frequency component may be sensor data having a frequency greater than 4 kHz.

After the sensor data is filtered, the process 420 moves to decision step 530 where a determination is made as to whether the component is a directional component in decision step 530. The determination can be performed by a processor, such as processor 205 depicted in fig. 2. If the determination is made that the directional component is processed, process 420 moves to step 540 where the directional component of the external event is processed. At decision step 530, if the determination is made that the directional component is not being processed, then process 420 moves to step 590 where the magnitude component of the external event is determined at step 590. Although fig. 5 depicts decision step 530 as determining whether the direction component is processed, it should be appreciated that decision step 530 may be configured to determine whether the magnitude component is processed. In this embodiment, a positive determination will cause process 420 to move to step 590, and a negative determination will cause process 420 to move to step 540.

Steps 540 to 570 determine the direction parameter of the external event. In an exemplary embodiment according to the invention, process 420 measures the rate of change of the directional component at step 540. In one embodiment, process 420 measures the rate of change of the low frequency component of the signal detected by the sensor module. In one embodiment, not shown in fig. 5, the rate of change measured in step 540 can be compared to a specified rate of change. The specified rate of change can act as a threshold for passing/failing the directional component associated with the dose dialing event. The specified rate of change can be determined experimentally, for example by measuring the rate of change of known dose dialing events to establish a rate of change threshold as the lowest measured rate of change. In a dose dialing event, a sensor module (e.g., sensor module 210) detects a signal indicative of an external event, and if the rate of change of the signal, either increasing or decreasing, is faster than the rate of change of the threshold, then the external event is indicative of a dose dialing event. Alternatively, if the sensor module collects a signal that changes at a rate slower than a specified rate of change, the external event is rejected as not complying with a dose dialing event. In an exemplary embodiment according to the present invention, the specified rate of change may be stored in working memory 250 or storage 280 and accessed by processor 205. In another embodiment, the specified rate of change may be based on the slew rate of the module 110.

After the rate of change is measured, process 420 moves to decision step 550 where a determination is made that the rate of change of the directional component is a positive rate of change.

If the determination is made that the rate of change of the directional component is a rate of change having a positive value, process 420 moves to step 560 where the directional component is determined to be increasing. In one embodiment, the determination that the direction is increasing indicates that the movement detected by the sensor module from the external event is a movement that simulates or appears to be a movement associated with operating the dose dial mechanism, increasing the dose of the injection device by one unit. In one embodiment, the increase indication may be an "dial-up" or "clockwise" operation of the dose dial mechanism.

If the determination is made that the rate of change of the directional component is not a rate of change having a positive value, e.g., the rate of change is negative, then process 420 moves to step 570 where the directional component is determined to be decreasing. In one embodiment, the determination that the direction is decreasing indicates that the sensor module detects that the movement from the external event is a movement that simulates or appears to be associated with operation of the dose dial mechanism to decrease the dose of the injection device by one unit. In one embodiment, the increase indication may be a "dial down" or "counter clockwise" operation of the dose dial mechanism. Although fig. 5 depicts the decision step 550 determining whether the rate of change is positive, it should be appreciated that the decision step 550 may be configured to determine whether the change dormitory rate is negative. In this embodiment, a positive determination would cause process 420 to move to step 570, while a negative determination would move process 420 to step 560.

If the determination at decision step 530 results in processing the magnitude component, process 420 moves to block 590 where the event magnitude is determined at block 590. In an exemplary embodiment according to the present invention, the amplitude component may relate to a high frequency component of the sensor data, as explained in detail above. The high frequency components can be transformed (via envelope detection and integration as known in the art) to generate a waveform. The magnitude (or loudness) of the external event may be inferred from the generated waveform. It should be appreciated that the above description is merely one embodiment and that other methods may be used to measure the magnitude component of the external event.

After the external event direction and magnitude parameters are determined, process 420 moves to step 580 where the event parameters are stored in a memory of the module, such as memory 250 depicted in FIG. 2, in step 580. After the event parameters, including but not limited to the magnitude and direction of the external event, are stored, process 420 ends at an end step.

Fig. 6 depicts a process 430 of an exemplary embodiment of determining that an event is a dose dialing event. In one embodiment, a dose dialing event is determined by the processor 205 retrieving data from the working memory 250 or the storage 280 and configured based on data from the event determination module 225, the threshold determination module 225, and the dialing event determination module 226.

The process 430 begins at a start step and then moves to step 605 where in step 605 the event parameters are retrieved from a memory, such as the working memory 205 depicted in FIG. 2. In one embodiment, the processor 205 is configured to access the working memory 250 to retrieve the event parameters determined according to fig. 5.

After the event parameters are obtained, the process moves to step 610 where, in step 610, event values are measured based on the event parameters. In one embodiment, the processor 205 can be configured to retrieve event parameters, including a direction component and a magnitude component, and combine the event parameter components to determine an event value or score. In an exemplary embodiment according to the invention, the low frequency waveform component is multiplied by the high frequency waveform component, the resulting waveform representing a score waveform associated with sensor data of an external event being processed. In another embodiment, the basis of the event value may be a rate of change detected by the sensor module (e.g., sensor module 210) associated with motion and/or vibration imparted to the injection device as a result of the external event.

After the event value or score is determined, process 430 moves to step 620 where a threshold is obtained in step 620. In an exemplary embodiment according to the invention, the instructions in the threshold determination module 224 can configure the processor 205 to obtain the threshold based at least in part on a specified threshold. In one embodiment, the threshold may be predetermined and stored in the storage 280 and/or the working memory 250. The threshold can be determined experimentally by running a representative number of controlled studies to isolate the dose dialing event from any extraneous perturbations or events. The controlled study can include measuring and/or monitoring controlled dose dialing events ("clicks"). In one embodiment, the threshold can be determined as the lowest value of any controlled dose dialing event. In another embodiment, threshold determination module 225 may include configuring the processor to determine the threshold based at least in part on a controlled study representing expected dose dialing events. In yet another embodiment, the threshold may be based on a rate of change associated with a known dose dialing event.

After obtaining the threshold, process 430 moves to step 635 where the event value is compared to the threshold in step 635. In one embodiment, the processor 205 can be configured to access event values and thresholds stored in the working memory 250 or the storage 280. In another embodiment, the threshold value may be specified as a formula for comparing the event value to a threshold value formula. In yet another embodiment, the threshold may be a predetermined rate of change associated with an expected dose dialing event.

Based on the comparison in step 625, the process 430 moves to decision step 630 where a determination is made as to whether the event value exceeds a threshold value in decision step 630. The determination can be performed by a processor, such as processor 205 depicted in fig. 2. If a determination is made that the event value does not exceed the threshold, process 430 rejects the external event and ends at the end step. The process then moves to decision step 330 as described in fig. 3.

If a determination is made that the event value exceeds the threshold, process 430 moves to step 635 where the external event is recorded as a dose dialing event. In one embodiment, the processor is capable of recording the external event as a dose dialing event in, for example, the processor 205 and working memory 250 depicted in fig. 2. In this way, the module is able to confirm an external event as a dose dialing event based on the event parameters and determine the direction of the dose dialing event. Thus, the module is able to count each operation of the dose dial mechanism and the direction of that operation, thereby counting the total selected dose of an injection event. In an exemplary embodiment according to the invention, a dose dialing event can be recorded when the event value exceeds the threshold and is the maximum event value within a 2ms event range. In this way, the module continues to monitor the event value of the external event and compares the values of the previous and subsequent events to determine if the event value is the maximum value within the time window. After the dose dialing event is recorded, process 430 ends at an end step, and as depicted in fig. 3, the process moves to decision step 330.

In another exemplary embodiment according to the present invention, additional sensor data may be processed in process 300 to provide additional event parameters in evaluating external events. For example, sounds characteristic of the injection device function (e.g., removal of a safety cap or injected medication) may be detected and processed. Such a sound may indicate that the detected external event relates to an unrelated event (e.g., an injection event) as opposed to a dialing event. In another embodiment, the movement or vibration associated with removing the headgear may be detected and processed. Such movement may indicate that the external event is associated with an injection event, but not a dose dialing event. In yet another embodiment, device orientation and motion may be detected and processed. For example, the orientation of the injection device for an injection event provides data that is different from data associated with dose dialing times. According to the above example, process 300 may be configured with additional detection means to isolate dose dialing events from other unrelated events. It should be appreciated that while an illustrative example is provided, process 300 can be configured with a detection device to support isolation of dose dialing events from other times.

Figures 7A-D depict graphs representing dose dialing event illustrations according to embodiments of the present invention. 7A-D each show the frequency of vibration detected by the sensor plotted against time.

Figure 7A shows the increase in dose caused by the user performing a double click dial out, i.e. the user operates the dose dial mechanism to increase the dose by two units. Despite the presence of manageable noise, as seen on the curve, there are two different events 710a and 710b representing separate dose dialing events. In one embodiment, module 110 detects dose dialing events using sensors, and detects the events and interprets the instructions by filtering and applying algorithms described in detail herein. Fig. 7B is similar to fig. 7A except that the user dials up the dose four increments resulting in four dose dialing events. Figures 7C and 7D show a situation where the user reduces the selected dose by dialing down the dose dial mechanism or performing a "click through".

Fig. 8 depicts an exemplary embodiment of an injection device 800 according to the present invention. The injection device 800 includes the same features as the injection device 100. The injection device 800 includes a body 808, the body 808 having an injection button 806 positioned on one end of the injection device 800. The injection button 808 is substantially similar to the injection button 106. The injection device 800 further includes a dose dialing mechanism 804 configured to allow a user to dial an injected dose. The dose dialing mechanism 804 operates substantially similar to the dose dialing mechanism 104. At the distal end of the body 808 is a smart cap 802, the smart cap 802 being configured to prevent a user from inadvertently contacting the syringe.

In an exemplary embodiment according to the present invention, the injection device 800 includes a module 810. Module 810 includes the essential features of module 110 and is configured toOperates in substantially the same manner as module 110. However, the module 810 is designed or designed as part of the smart cap 802. In this embodiment, the module 810 is attached to the injection device body 808 without changing the external dimensions or form of the injection device 800 or interfering with the functionality of the injection device 800. In an exemplary embodiment according to the invention, the injection device 800 may be a PHYSIOJECT from Becton Dickinson^TMAuto injector, VYSTRA^TMDisposable pens or reusable pens. It should be recognized, however, that other syringes are also contemplated as falling within the scope of the present invention.

The module 810 allows a user to view one or more status indicators 812 mounted on the module 810. The one or more indicators may be part of module 810 and may be capable of indicating a condition or status of the device. Status indicators 812 may include one or more lights such as light emitting diodes ("LEDs") or any other visual, audible, or touch stimulus. The use case or condition may include, but is not limited to, an out-of-range condition (e.g., loss of connection) or a temperature alarm. Indicator 812 may operate in substantially the same manner as indicator 112.

In another exemplary embodiment according to the present invention, the module 810 may include a micro switch (not shown). The microswitch may be operated to activate the dose detection module 810. In one embodiment, the micro-switch may be operated when the smart cap 802 is placed onto the injection device 800. In this regard, when the smart cap 802 is placed on the injection device 800, the module 810 may be activated, thereby protecting the syringe; when the smart cap 802 is removed due to an injection event, the module 810 is deactivated. By deactivating the module 810 upon removal of the smart cap 802, subsequent external events cannot be detected by the module 810 and the movement of the injection device 800 to perform an injection event is removed according to the dose dialing event determination algorithm. In another embodiment, removal of the smart cap 802 may not disable the module 810, thereby allowing continuous uninterrupted monitoring of the injection device 800. In this embodiment, removal of the smart cap 802 to perform an injection event may cause a device status indicator to be passed to the module 810 to indicate that any external motion detected upon removal of the smart cap 802 is an extraneous or injection event, but not a dose dialing event.

The foregoing detailed description is directed to certain specific embodiments of the invention. The invention may, however, be embodied in many different forms. It should be apparent that the aspects herein may be embodied in a wide variety of forms and that any specific structure, function, or both being disclosed herein is merely representative. Those skilled in the art should appreciate, based on the teachings herein, that an aspect disclosed herein may be implemented independently of any other aspects and that two or more of these aspects may be combined in various ways without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention. For example, an apparatus may be implemented using any number of the aspects set forth herein or a method may be practiced using any number of the aspects set forth herein. In addition, such an apparatus or method may be implemented using other structure, functionality, or structure and functionality in addition to or other than one or more of the aspects set forth herein.

Further, the systems and methods described herein may be implemented on different drug delivery or injection devices. These drug delivery or injection devices include insulin injection devices for diabetes, as well as injection devices designed for other diseases.

Moreover, the systems and methods described herein may be implemented using a drug delivery or injection device in communication with a computing device. These computing devices include both mobile and non-mobile devices, as well as general purpose or special purpose computing system environments or configurations. Examples of computing systems, environments, and/or configurations that may be suitable for use with the invention include, but are not limited to, personal computers, server computers, hand-held or laptop devices, multiprocessor systems, microprocessor-based systems, programmable consumer electronics, network PCs, minicomputers, mainframe computers, distributed computing environments that include any of the above systems or devices, and the like. Further, the systems and methods may be implemented on mobile devices, such as cell phones, smart phones, Personal Digital Assistants (PDAs), Ultra Mobile Personal Computers (UMPCs), Mobile Internet Devices (MIDs), etc.

It will be understood that any reference herein to "first," "second," etc., does not generally limit the number or order of such elements or steps. Rather, these labels may be used herein as a convenient method of distinguishing between two or more elements or instances of an element. Thus, reference to first and second elements does not mean that only two elements may be used herein or that the first element must somehow precede the second element. Also, a group of elements may include one or more than one element unless explicitly stated otherwise. In addition, the format term "at least one: A. b or C "means" a or B or C or any combination of these elements. "

As used herein, the term "determining" includes a wide range of actions. For example, "determining or determining" can include evaluating, computing, processing, reasoning about, investigating, reviewing (e.g., reviewing a table, database or other data structure), determining, or the like. Additionally, "determining or determining" may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), and the like. Also, "determining" may include resolving, selecting, choosing, identifying, and the like.

As used herein, a phrase referring to "at least one of a list of terms refers to any combination of these terms. As an example, "at least one: a. b or c "are intended to encompass: a. b, c, a-b, a-c, b-c and a-b-c.

The steps of a method or process described in connection with the embodiments disclosed herein may be embodied directly in hardware, in a software module executed by a processor, or in a combination of the two. A software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of non-transitory medium known in the art. An exemplary computer readable storage medium is coupled to the processor, and the processor can read information from, and write information to, the computer readable storage medium. In the alternative, the storage medium may be integral to the processor. The processor and the storage medium may reside in an ASIC. The ASIC may reside in a user terminal, camera, or other device. In the alternative, the processor and the storage medium may reside as discrete components in a user terminal, camera, or other apparatus.

If the functions are implemented in software, the functions may be stored on or transmitted over as one or more instructions or code on a computer-readable medium. The steps of a method or algorithm disclosed herein or a method may be embodied in a software module located on a computer-readable medium and executable by a processor. Computer-readable media includes computer storage media and communication media, where storage media may be any available media that can be accessed by a computer; communication media includes any medium that can communicate a computer program from one place to another. By way of example, and not limitation, such computer-readable media can comprise RAM, ROM, EEPROM, CD-ROM or other medium for storing desired program code in the form of instructions or data structures and accessible by a computer. Also, any connection is properly termed a computer-readable medium. Hard disks and magnetic disks, as used herein, include Compact Disks (CDs), laser disks, optical disks, Digital Versatile Disks (DVDs), floppy disks and blu-ray disks where disks usually reproduce data magnetically, while disks reproduce data optically with lasers. Combinations of the above should also be included within the scope of computer-readable media. Additionally, the operations of a method or algorithm may reside as one or any combination or set of codes and instructions on a machine readable medium and a computer readable medium, which may be incorporated into a computer program product.

Various modifications to the implementations described in the disclosure may be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations without departing from the spirit or scope of the disclosure. Thus, the claims are not intended to be limited to the embodiments shown herein but are to be accorded the widest scope consistent with the present disclosure, principles and novel features disclosed herein. The word "exemplary" is used exclusively herein to mean "serving as an example, instance, or illustration. Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. Additionally, one of ordinary skill in the art will readily appreciate that the terms "upper" and "lower" are sometimes used to readily describe views, meaning relative positions that correspond to the orientation of the view on a properly oriented page, but do not reflect the proper orientation of the IMOD as implemented.

Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

Headings are included herein for reference and to aid in determining the various sections. These headings are not intended to limit the scope of the concepts described herein. These concepts may be applied throughout the specification.

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic concepts defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (24)

1. A method for detecting at least one dialing event of an injection device, comprising:

providing an injection device for administering a dose, the injection device comprising a dose dialing mechanism configured such that rotation of the dose dialing mechanism in a first direction causes an increase in a dose, rotation of the dose dialing mechanism in a second direction causes a decrease in a dose, the first direction being different from the second direction;

detecting, by one or more sensors attached to a body of the injection device, a direction and magnitude of an impact transmitted through the injection device, wherein the impact is related to movement of the dose dialing mechanism;

obtaining, by a processor, sensor data based on a direction and magnitude of the impact from the one or more sensors;

determining, by the processor, a direction of rotation of the dose dialing mechanism based on the detected direction of the impulse delivered by the injection device; and

distinguishing, by the processor, a dose increase event and a dose decrease event based on the determined direction of rotation of the dose dialing mechanism.

2. The method of claim 1, wherein the shock includes a vibration component.

3. The method of claim 2, wherein the detecting the direction and magnitude of the impact with one or more sensors attached to a body of the injection device comprises detecting the vibration with at least one sensor.

4. The method of claim 1, wherein the processor is configured to determine a magnitude of motion of the dose dialing mechanism, wherein the magnitude of motion of the dose dialing mechanism is a function of the shock.

5. The method of claim 1, further comprising determining, by a processor, a movement of the dose dialing mechanism,

comparing sensor data based on the direction and magnitude of the impact to a threshold, wherein movement of the dose dialing mechanism is detectable only if the sensor data exceeds the threshold.

6. The method of claim 1, further comprising: counting one or more dialing events, wherein each counted dialing event is associated with a separate impulse detected by the one or more sensors.

7. The method of claim 6, wherein the counted one or more dialing events is related to a dose size of the injection device.

8. The method of claim 7, further comprising:

a dose magnitude is communicated to a communication device, wherein a subsequent dose magnitude is based on the communicated dose magnitude.

9. A module for detecting dose dialing parameters, comprising:

a carrier configured to mate with an injection device, the injection device including a dose dialing mechanism configured such that rotation of the dose dialing mechanism in a first direction causes an increase in a dose, rotation of the dose dialing mechanism in a second direction causes a decrease in the dose, the first direction being different from the second direction;

one or more sensors mounted on the carrier and configured to detect a direction and magnitude of an impact transmitted through the injection device and to generate sensor data based on the direction and magnitude of the impact, wherein the impact is related to movement of the dose dialing mechanism; and

a processor configured to acquire the sensor data from the one or more sensors;

determining a direction of rotation of the dose dial mechanism based on the detected direction of the impulse delivered by the injection device; and

a dose increase event and a dose decrease event are distinguished based on the determined direction of rotation of the dose dialing mechanism.

10. The module of claim 9, wherein the module is configured to fit within a cover element of the injection device.

11. The module of claim 9, wherein the module is configured to be mounted externally to the injection device.

12. The module of claim 9, wherein the presence of the module does not affect an already existing function of the injection device.

13. The module of claim 9, wherein the processor is configured to derive event parameters from the sensor data, the parameters being a function of external events, and the processor is configured to detect a dialing event when the parameters exceed a threshold.

14. The module of claim 9, wherein the sensor is selected from the group consisting of a pressure sensor, a sound sensor, a vibration sensor, a motion sensor, and an orientation sensor.

15. The module of claim 9, wherein the shock includes a vibration component.

16. A medication injection device comprising:

a body;

a dose dialing mechanism configured such that rotation of the dose dialing mechanism in a first direction causes an increase in a dose and rotation of the dose dialing mechanism in a second direction causes a decrease in a dose, the first direction being different from the second direction;

one or more sensors attached to the body and configured to detect a direction and magnitude of an impact transmitted through the injection device and generate sensor data based on the direction and magnitude of the impact, wherein the impact is related to movement of the dose dialing mechanism; and

a processor operatively connected to the one or more sensors

And is configured to:

determining a direction of rotation of the dose dial mechanism based on the detected direction of the impulse delivered by the injection device; and

a dose increase event and a dose decrease event are distinguished based on the determined direction of rotation of the dose dialing mechanism.

17. The injection device of claim 16, wherein the shock comprises a constant vibration component.

18. The injection device of claim 16, wherein the one or more sensors and processor are mounted on a carrier.

19. The injection device of claim 18, wherein the carrier is removably mounted on the body.

20. The injection device of claim 16, wherein the processor is further configured to determine a magnitude of the movement of the dose dialing mechanism, wherein the magnitude of the movement of the dose dialing mechanism is a function of the impulse.

21. The injection device of claim 16, further comprising a memory component, wherein the memory component and the processor are further collectively configured to determine the movement of the dose dialing mechanism by:

comparing sensor data based on the magnitude and direction of the impact to a threshold, wherein movement of the dose dialing mechanism is detectable only if the sensor data exceeds the threshold.

22. The injection device of claim 16, the processor further configured to count one or more dialing events, wherein each counted dialing event relates to a separate impact detected by one or more sensors.

23. The injection device of claim 22, wherein one or more dialing events are counted relating to a dose size of the injection device.

24. The injection device of claim 23, the processor further configured to:

communicating the dose size value to a communication device, wherein a subsequent dose size value is based on the communicated dose size value.

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